In the process of implementation of REGULATION (EU) 2019/6 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 11 December 2018 on veterinary medicinal products and repealing Directive 2001/82/EC members of the association of European Manufacturers of Autogenous Vaccines and Sera – EMAV - have compiled common positions for a dedicated GMP Annex for Autogenous vaccines. This proposal defines future standards for the production of Autogenous vaccines to preserve their quality without hindering their manufacturing and availability.
This position paper is an invitation of EMAV to competent authorities, users and other stakeholders to define a new standard for manufacturing and for a secured availability of Autogenous vaccines in the future.
This position paper would become part of the workshop “AUTOGENOUS VACCINES: QUALITY OF PRODUCTION AND MOVEMENT IN A COMMON MARKET”, organized by EMAV and IABS for September 14th – 16th as a hybrid meeting at Munich University LMU too.
The results of the scientific excursus will be incorporated in a IABS – EMAV meeting report and will be shared with all participants of the workshop and all people interested in.
Download the position paper: https://www.emav.be/position-papers